This part of ISO 11608 specifies requirements and test methods for the automated functions provides of needle - -based injection systems with automated functions provides (NIS - AUTO), for the administration of medicinal products in humans.
Reference is made to the need for force and/or the torque testing in certain sections covering priming, dosed setting, actuation, the needle insertion and retraction, disabling the NIS - AUTO, needle shielding, needle hiding, sharps injury protection, and needle removal. Foir example: "" according to the instructions for use there shall be measurements made, where appropriate (for example, the torque to rotate a safety lock or force to operate a button)"